PlainRecalls
FDA Drug Low Class III Terminated

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.

Reported: August 14, 2024 Initiated: July 2, 2024 #D-0628-2024

Product Description

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.

Reason for Recall

Defective container: potential for non-sealed pouches which can lead to product leakage.

Details

Units Affected
13,200 cartons
Distribution
Nationwide in the US.
Location
Somerset, NJ

Frequently Asked Questions

What product was recalled?
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.. Recalled by Novel Laboratories, Inc. d.b.a Lupin Somerset. Units affected: 13,200 cartons.
Why was this product recalled?
Defective container: potential for non-sealed pouches which can lead to product leakage.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2024. Severity: Low. Recall number: D-0628-2024.